Ensuring the accurate assessment of medical devices in the post market phase is critical. The implications of this assessment, place importance on the health and safety of patients, the viability of the business, both in terms of marketing and any resulting litigation or recall of the product. Significantly, the regulations concerning medical devices in the post market phase require life cycle management of all the product characteristics and thereby continuous assessment of risk.
The risk of the product determines whether a Post Market Clinical Follow Up or a Registry Study is required. Vigilance Reporting is necessary to analyze the data from clinical studies to determine the safety of the device.
This webinar discusses Post market Clinical Follow- up studies and Device Registries. It describes the choice of the two types of studies and the issue of risk. Vigilance reporting is important when assessing the safety and performance of the device. All of the data attained on the device whether it is from clinical studies – a PMCF or Registry as well as Vigilance Reporting needs to be integrated into the risk management documentation so an accurate assessment can be made on the medical device.
Sunita Ahir, PhD, Director, Regulatory Affairs (EU), Premier Research
Dr Sunita Ahir advises and supports medical device companies on the CE marking process, Authorized Representation in the EU and compliance issues. Sunita has extensive experience in the medical device field having worked for the British Standards Institute (BSi) Healthcare division as a technical expert where she reviewed Class IIb and Class III submissions for CE marking. Her other responsibilities included technical auditing, ISO 13485 and project management for many companies in the medical device field. Sunita has a Master`s degree from Cranfield University and a PhD in Biomedical Engineering from University College London in the UK.
Who Should Attend?
- Regulatory professionals
- Regulatory consultants
- Medical device regulatory professionals involved in clinical development (Managers, Directors, VPs)
- Clinical project managers and directors
- Clinical specialists
- Pharmacovigilance and safety representatives
- Senior industry executives
- Medical experts
Premier Research is a leading global contract research organization serving biotech, Pharmaceutical and medical technology companies. The company’s D-TARGET medical devices and diagnostics unit has conducted more than 340 clinical research projects and recruited 35,000 patients.
The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.
Premier Research has 21 offices (seven in North America, 14 in Europe) and operates in 23 countries. It employs 1,200 clinical professionals dedicated first and foremost to fulfilling each customer’s requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.
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